510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Bifurcated Suction/Irrigat Tubing Set W/Push Butto

K926477510(k) TraditionalCleared Nov 12, 1993318-day reviewClass I21 CFR 878.4200Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Core Dynamics, Inc. · GBW Catheter, Peritoneal

Cleared on Nov 12, 1993 after a 318-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 6 times.

Decided
Nov 12, 1993
Review
318 days
Class
Class I
Product code
GBW
Recalls
6
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K926477Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 27, 2016Class IIZ-0129-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Jun 27, 2016Class IIZ-0130-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Jun 27, 2016Class IIZ-0132-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Jun 27, 2016Class IIZ-0133-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Jun 27, 2016Class IIZ-0134-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Jun 27, 2016Class IIZ-0135-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GBW devices

GBW Catheter, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBW

FDA has decided no GBW device since 2007.

Median 510(k) review, days · GBW

Too few GBW 510(k)s in any year since 2007 to give a median.

Recalls per year · GBW

6in 2016

2007: 12009: 12015: 12016: 62026 (partial year): 1, 1 Class I
2007high 6 (2016) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GBW

28in 2023

2007: 12008: 22010: 12011: 12012: 22013: 22014: 12016: 32017: 212018: 102019: 12020: 32021: 82022: 62023: 28
2007high 28 (2023) · low 0 (2009)2025

MAUDE reports naming product code GBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11
20080—02
20090—10
20100—01
20110—01
20120—02
20130—02
20140—01
20150—10
20160—63
20170—021
20180—010
20190—01
20200—03
20210—08
20220—06
20230—028
20240—00
20250—00
20260—1 (1)—

More from Core Dynamics, Inc.

23 FDA decisions under this applicant name. See the company

  • K992250Core Audible Trocar IICore Dynamics, Inc. · 1999
  • K992190Core PouchCore Dynamics, Inc. · 1999
  • K955490Laparoscopic KnitterCore Dynamics, Inc. · 1996
  • K953903Laparoscopic Trocar Obturator, 5MM, 10/11MM, 10/12MMCore Dynamics, Inc. · 1995
  • K953409Laparoscopic TrocarCore Dynamics, Inc. · 1995

Recent decisions in GBW

The GBW category page

  • K992907IntraducerTaut, Inc. · 19991 recall
  • K992904Mini-PortTaut, Inc. · 1999
  • K972112Intraducer Port SC Catalog#31275,31035,30915, and 31450Taut, Inc. · 1997
  • K961194Antimicrobial Mediastinal Silicone DrainSil-Med Corp. · 1996
  • K960426Medicomp Flexi-Smooth Wound Drainage CatheterMedical Components, Inc. · 1996

https://510kreport.com/device/K926477 · printed Nov 5, 2026

Cite this page

510(k) Report. “K926477: Bifurcated Suction/Irrigat Tubing Set W/Push Butto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K926477

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026